Protective Effect of Early High Dose stATins On Cardiovascular and Renal Events in Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— PRATO-ACS  

Official title:

The Protective Effect of Early High Dose High-intensity Statins on Cardiovascular and Renal Events in Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04087200
• Other study ID #: OSS 15.161
• Status: Recruiting
• Start date: December 1, 2016
• Est. completion date: December 1, 2026

Study information

• Verified date: September 2019
• Source: Centro Cardiopatici Toscani
• Contact: Anna Toso, MD
• Phone: 00393387982507
• Email: anna.toso[@]libero.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Registration of all ACS patients (STEMI and NSTEMI) admitted to the cardiology ward and scheduled for early invasive strategy. The aim is to evaluate the protective effects of early (on admission) high-dose high-potency statin therapy on early and mid-term cardiac and renal events in this subset of patients.

Description:

Statin-naive patients and those on statin therapy with ACS who are admitted to the cardiology ward of our public (National Health Service) hospital and are scheduled for early invasive strategy receive immediately on admission, always before angiographic procedure, high-dose statin therapy. Either atorvastatin 80 mg or rosuvastatin 40 mg is administered at the discretion of the physician. During hospitalization various pertinent cardiac and renal parameters, including hematological, angiographic, clinical data are registered in a dedicated database. Clinical follow-up and hematological analysis are done 1 month after discharge. A second follow-up, either clinical or by telephone, is done 1 year after discharge.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Acute coronary syndrome (ST elevation and non ST elevation)

• Early invasive strategy

Exclusion Criteria:

• contraindication to statin therapy

• refusal of consent

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
Italy	Cardiology Division, Prato Hospital	Prato

Sponsors (2)

Lead Sponsor	Collaborator
Centro Cardiopatici Toscani	Azienda USL 4 Prato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of age and frailty profile on primary and secondary outcomes	Frailty evaluation (combination of FRAIL scale questionnaire and hand-grip strength measurement)	Up to 1 month
Primary	Acute renal function changes	Changes in creatinine and/or cystatine values	Within 72 hours after hospital admission
Primary	Inflammatory profile changes	Changes from baseline in CRP values	up to 1 month
Primary	Lipid profile changes	Changes from baseline in cholesterol values	up to 1 month
Primary	Platelet count	Changes from baseline in platelet count	up to 1 month
Primary	Platelet volume	Changes from baseline in platelet volume	up to 1 month
Primary	Platelet aggregation profile	Changes from baseline in platelet reactivity (Verify Now)	up to 1 month
Secondary	Major cardiovascular adverse events	Death, myocardial infarction, stroke or coronary revascularization	up to 12 months
Secondary	Renal function changes	glomerular filtration rate	Changes from baseline at 1 month
Secondary	Major adverse cardiovascular and renal adverse events	Death, myocardial infarction, stroke, coronary revascularization or glomerular filtration rate reduction > = 25% compared to baseline	up to 1 month